Evaluation of Cemiplimab in Combination With Platinum-Doublet Chemotherapy in First-Line (1L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) in Adult United States (US) Patients

Active, not recruiting

• Conditions: Advanced Non-small Cell Lung Cancer
• Interventions: Drug: REGN2810; Other: Platinum-doublet chemotherapy

• Registration Number: NCT06269133
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

This multi-year cohort study will assess the real-world safety and effectiveness of 1L treatment with cemiplimab in combination with platinum-doublet chemotherapy across advanced NSCLC patient subgroups defined by age, sex, race, and ethnicity. Patients will be retrospectively identified from at least two US electronic health record (EHR)-based databases.

Detailed Description

Patients and baseline variables will be captured retrospectively, but outcome measures will be prospectively ascertained.

Study Timeline

• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-13
• Study Start: 2024-02-21
• Study First Posted: 2024-02-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13
• Primary Completion: 2027-03-31
• Study Completion: 2027-06-23

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Advanced non-small cell lung cancer (aNSCLC) (defined as stage IIIB/C or stage IV) treated with cemiplimab in combination with platinum-doublet chemotherapy in the 1L setting from Nov 2022 to Jun 2026 as described in the protocol

Key

Exclusion Criteria

1. Patients who have EGFR, ALK or ROS1 variants

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Patients	REGN2810	Patients who have received cemiplimab in combination with platinum-doublet chemotherapy for the 1L treatment of aNSCLC in the US with no documented EGFR, ALK and ROS1 variants as described in the protocol.
Study Patients	Platinum-doublet chemotherapy	Patients who have received cemiplimab in combination with platinum-doublet chemotherapy for the 1L treatment of aNSCLC in the US with no documented EGFR, ALK and ROS1 variants as described in the protocol.

Primary Outcome Measures

Name	Time	Method
Any treatment-emergent immune-mediated adverse event (imAE)	Approximately 3 years
Specific treatment-emergent imAEs	Approximately 3 years
Real-world response rate (rwRR)	Approximately 3 years
Any treatment-emergent imAE resulting in death	Approximately 3 years
Any treatment-emergent imAE resulting in hospitalization	Approximately 3 years

Secondary Outcome Measures

Name	Time	Method
Real-world duration of response (rwDOR)	Approximately 3 years
IRR resulting in death	Approximately 3 years
Treatment-emergent immune-mediated adverse events (imAEs)	Approximately 3 years
Real-world progression-free survival (rwPFS)	Approximately 3 years
Infusion-related reaction (IRR)	Approximately 3 years
IRR resulting in hospitalization	Approximately 3 years
Real-world overall survival (rwOS)	Approximately 3 years

Trial Locations

Locations (1)

Regeneron Research Facility; 🇺🇸 Tarrytown, New York, United States